Abstract:

Objective  To observe the efficacy and safety of the combination of Endostar therapy with capecitabine and oxaliplatin therapy as a first-line treatment for patients with advanced biliary tract carcinoma. Methods Records were retrospectively reviewed for 42 patients with stage Ⅳ primary biliary tract carcinoma confirmed by pathology and imaging，who were treated at our hospital from January 2008 to December 2013. Eighteen patients were treated with Endostar+XELOX，while 24 were treated with XELOX alone. The XELOX regimen involved capecitabine at 1.25 g/m2， po，d1-d14 and oxaliplatin at 85 mg/m2，ivgtt， d1. Endostar was given at a dose of 15 mg，ivgtt， d1-d14，on a 21-day cycle. After 2 cycles，efficacy， quality of life（QOL），safety，median  progression-free survival （mPFS） and median overall survival（mOS） were compared between the two treatment groups. Results In the XELOX group after 2 treatment cycles，no patient was in CR，6 were in PR，8 were in SD，and 10 were in PD；the response rate（RR） was 25.0%， disease control rate （DCR） was 58.3%，mPFS was 5.0 months and mOS was 9.5 months. QOL improved as a result of treatment，and 66.7% patients were in stable condition. In the Endostar+XELOX group after 2 cycles， no patient was in CR，5 were in PR，6 were in SD，and 7 were in PD；RR was 27.7%，DCR was 61.1%，mPFS was 7.5 months and mOS was 14.0 months. QOL improved as a result of therapy，and 77.8% of patients achieved a stable condition. mPFS and mOS were significantly longer for patients who received combination therapy（P<0.05）. The two therapies were associated with similar types and rates of adverse events，the most frequent of which were gastrointestinal reactions，hand-foot syndrome，myelosuppression，neurotoxicity，and stomatitis（mainly gradeⅠ-Ⅱ）. Conclusion Endostar+XELOX shows good efficacy as a first-line treatment for advanced biliary tract carcinoma，and it is well tolerated， justifying its further study and potentially wider implementation in the clinic.

Key words:  Biliary tract neoplasm, XELOX regimen, Rh-endostatin/Endostar, Combination therapy, Efficacy